| CTRI Number |
CTRI/2025/08/093344 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Randomized Clinical Trial Comparing Backward and Side Walking Exercises with Visual and Auditory Cueing for Enhancing Gait Speed and Balance in Parkinson’s Disease |
|
Scientific Title of Study
|
Backward and Side Walking Training versus Visual and Auditory Cueing techniques to improve Gait Speed and Balance in Parkinson’s Disease A randomized clinical trail |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sahana D L |
| Designation |
Physiotherapist |
| Affiliation |
Cauvery college of physiotherapy |
| Address |
MPT Classroom 1, Department of Neurological Science, 1st floor, Building 1, Cauvery College of Physiotherapy, KBL Layout near Devagowda Circle, Mysore, Karnataka
Neurological Science, 1st floor, Building 1, Cauvery College of Physiotherapy, KBL Layout near Devagowda Circle, Mysore, Karnataka
Mysore
KARNATAKA
570028
India |
| Phone |
9482075838 |
| Fax |
|
| Email |
sahanadl25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rakesh M |
| Designation |
Associate professor |
| Affiliation |
Cauvery college of physiotherapy |
| Address |
Department of Neurological Science, 1st floor, building 1, Cauvery College of Physiotherapy, KBL Layout near Devagowda Circle, Mysore Karnataka
Department of Neurological Science, 1st floor, building 1, Cauvery College of Physiotherapy, KBL Layout near Devagowda Circle, Mysore Karnataka
Mysore
KARNATAKA
570028
India |
| Phone |
7795771545 |
| Fax |
|
| Email |
rakeshmanju098@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sahana D L |
| Designation |
Physiotherapist |
| Affiliation |
Cauvery college of physiotherapy |
| Address |
MPT Classroom 1, 1st floor, building 1, Department of Neurological Science, Cauvery College of Physiotherapy, KBL Layout near Devagowda Circle, Mysore, Karnataka
MPT Classroom 1, 1st floor, building 1, Department of Neurological Science, Cauvery College of Physiotherapy, KBL Layout near Devagowda Circle, Mysore, Karnataka
Mysore
KARNATAKA
570028
India |
| Phone |
9482075838 |
| Fax |
|
| Email |
sahanadl25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Cauvery college of physiotherapy, KBL Layout near deve gowda circle mysore, Karnataka 570028 |
|
|
Primary Sponsor
|
| Name |
Sahana D L |
| Address |
MPT Classroom 1, department of Neuroscience, 1st floor, builiding 1, cauvery college of physiotherapy, KBL Layout near deve gowda circle mysore karnataka 570028 |
| Type of Sponsor |
Other [private college ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rakesh M PT |
OPD Cauvery college of physiotherapy |
OPD, 1st floor, builiding 1, cauvery college of physiotherapy, KBL Layout near deve gowda circle mysore karnataka
MPT Classroom 1, 1st floor, builiding 1, cauvery college of physiotherapy, KBL Layout near deve gowda circle mysore karnataka
Mysore
KARNATAKA |
7795771545
rakeshmanju098@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee cauvery heart and multispeciality hospital, mysore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Parkinson Disease |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Backward walking and side walking |
Backward walking and side walking is given for 30 minutes, 3 days per week for 4 weeks. |
| Comparator Agent |
visual cueing and auditory cueing |
visual cueing and auditory cueing is given for 30 minutes, 3 days per week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Parkinsonism with Hoehn and Yahr stage II to III
is considered.
Both genders are included.
Berg Balance Score between medium fall risk 21 to 40 and low fall risk 41 to 51 patients are
included in this study.
Patients who can walk for 10 meters without any walking aids
Age above 60 years.
|
|
| ExclusionCriteria |
| Details |
Blindness or vision problems.
vestibular impairments.
Orthopaedic impairments or conditions like TKR
Chronic stage of Parkinson’s disease.
Parkinson’s plus syndrome patients
Berg Balance Score between high fall risk 0 to 2 and low fall risk 41 to 51 patients is
excluded from this study.
Age below 60 years. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Berg Balance Scale |
Before and after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 10 meter walk test |
Before & after intervention |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Parkinson’s
disease is a
progressive neurodegenerative disorder that will significantly affect gait and balance, thereby increasing the risk of falls and
functional dependency. This randomized clinical trial aims to compare the effectiveness of
Backward Walking and Side Walking training versus Visual Cueing and Auditory
Cueing techniques in improving gait speed and balance in individuals with
Parkinson’s disease, particularly those in Hoehn and Yahr stages II and III.The study will
include a total of 36 participants who will be randomly divided
into two groups: Group A will
receive Backward Walking and Side Walking training, while Group
B will receive
Visual and Auditory Cueing training. The intervention will last
for 30 minutes, three times a week, for four weeks. The primary outcome
measures will be the
Berg Balance Scale to assess balance and the 10 Meter Walk Test to assess gait speed. |